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FDA 510(k) Application Details - K142984
Device Classification Name
Light, Surgical, Ceiling Mounted
More FDA Info for this Device
510(K) Number
K142984
Device Name
Light, Surgical, Ceiling Mounted
Applicant
SUNNEX, INC.
9319 FORSYTH PARK DRIVE
CHARLOTTE, NC 28273 US
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Contact
TISH MENDICK
Other 510(k) Applications for this Contact
Regulation Number
878.4580
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Classification Product Code
FSY
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More FDA Info for this Product Code
Date Received
10/16/2014
Decision Date
10/29/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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